Kornimate/medical-research-clean huggingface dataset:
oct in diagnosis of irregular corneas

Conditions: Keratoconus; Corneal Opacity; Corneal Dystrophy

Summary: this main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions. the primary goal will be achieved by using optical coherence tomography (oct) to: 1. develop an oct-based system to classify and evaluate corneal-shape irregularities. 2. develop oct metrics for more sensitive detection of keratoconus progression. 3. develop oct-and-topography guided phototherapeutic keratectomy (ptk) for irregular corneas.


Eligibility criteria:
inclusion criteria: group a: * keratoconus: 1. cdva ≥ 20/25 in the better eye; and both of the following in the worse eye 2. topography characteristic of keratoconus or pellucid marginal degeneration * contact lens-related corneal warpage: 1. contact lens use; and 2. topography irregularities * dry eye: 1. symptoms of dry eye documented by ocular surface disease index (osdi) questionnaire score ≥ 30; and 2. topography irregularities 3. presence of punctate epithelial erosion on exam with surface staining 4. aqueous deficiency or evaporative dry eye * epithelial basement membrane dystrophy (ebmd): 1. negative corneal fluorescein staining; and 2. corneal opacities; and 3. topography irregularities * stromal addition or subtraction: 1. scars; or 2. salzmann's degeneration; or 3. stromal dystrophies; or 4. complication (visual complaints) after lasik or photorefractive keratectomy (prk) * stromal distortion: 1. radial keratectomy (rk); or 2. corneal transplants. * normal controls: 1. healthy eyes with no previous eye procedures/surgeries. group b: participants will be selected from the keratoconus population in group a based on topography findings. group c: participants will be selected from the stromal addition/subtraction and stromal distortion populations of group a if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from ptk. exclusion criteria (all groups): * inability to give informed consent. * inability to maintain fixation for oct imaging. * inability to commit to required study visits. * eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery. * previous corneal surgeries if considered as a keratoconus participant. * pregnancy or breastfeeding.

Keywords: oct keratoconus
a study to evaluate efficacy of ym060 on diarrhea-predominant irritable bowel syndrome (d-ibs) in female patients

Conditions: Irritable Bowel Syndrome

Summary: a study to verify the superiority of ym060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (d-ibs) and to evaluate its safety.


Eligibility criteria:
inclusion criteria: * patients meeting the rome iii diagnostic criteria * loose (mushy) or watery stools within the last 3 months * abdominal discomfort and/or pain during their non-menstrual period exclusion criteria: * patients with a history of surgical resection of the stomach, small intestine or large intestine * patients with a history or current diagnosis of inflammatory bowel disease (crohn's disease or colitis ulcerative) * patients with a history or current diagnosis of colitis ischemic * patients with a current diagnosis of enteritis infectious * patients with a current diagnosis of hyperthyroidism or hypothyroidism * patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study * patients with a history or current diagnosis of malignant tumor * patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Keywords: diarrhea ibs colonic disease ym060 ramosetron
clinical trial on the use of autologous bone marrow stem cells in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of amyotrophic lateral sclerosis patients.

patients with amyotrophic lateral sclerosis (als) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. no treatment has changed its natural history. intraspinal injections of bone marrow mononuclear cells (mnc) have been able to ameliorate the course of als in murine models, acting as pumps of trophic factors that keep the motoneurons functional. we have designed a phase i/ii clinical trial to check the feasibility of this approach in humans.

Eligibility criteria:
inclusion criteria: * diagnose established following the world federation of neurology criteria * more than 6 and less than 36 months of evolution of the disease * medullar onset of the disease * more than 20 and less than 65 years old * forced vital capacity equal or superior to 50% * total time of oxygen saturation \<90% inferior to 2% of the sleeping time * signed informed consent exclusion criteria: * neurological or psychiatric concomitant disease * need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube * concomitant systemic disease * treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months * inclusion in other clinical trials * unability to understand the informed consent

Keywords: amyotrophic lateral sclerosis bone marrow stem cells autologous safety
ertapenem administered subcutaneously versus intravenously

Conditions: Urinary Tract Infections

Summary: infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. in this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though. patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. in this context, we hypothesize ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. a non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.

this is a randomized open label clinical trial to evaluate ertapenem administered subcutaneously is non-inferior to the same antibiotic intravenously to treat urinary tract infections in oncological palliative care patients. the study will be performed at the palliative care unit (pcu) of the national cancer institute of brazil josé alencar gomes da silva (inca), a 56-bed hospital and the only public hospital for cancer palliative care located in the city of rio de janeiro, brazil. a sample of 82 patients was estimated, considering the level of significance (alpha) of unilateral 2.5%, the power of the study (1-beta) of 80%, the non-inferiority limit of 4%, and success percentages in the groups control and experimental studies of 92% and 100%, respectively. once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

Eligibility criteria:
inclusion criteria: * any type of cancer in palliative care; * urinary tract infection; * informed consent assigned by the patient or legal representative. exclusion criteria: * neutropenia; * unconsciousness.

Keywords: subcutaneous ertapenem urinary tract infection advanced cancer palliative care
from the characterization of the cholesterol-epoxide pathway deregulation to new therapeutic perspectives in breast cancers

Conditions: Breast Cancer

Summary: the main objective of our project is to further characterize the deregulation of ce (cholesterol epoxides) metabolism in different moleculars subtypes of bc (bc=breast cancer) (luminal a and b, her2+ and triple negative). we will study not only the level of expression of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved were identified in our preclinical work (gsta1 (glutathione s-transferase a1 ), dhcr7, d8d7i, 11βhsd2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates of ce (hydrolyses cholesterols-5,6-epoxide ), ct (into cholestane-3β, 5α, 6β triol ), dda (dendrogenin a)and ocdo (6-oxo-cholestan-3β, 5α-diol ). our preliminary results demonstrate the feasibility of these dosages. we will also establish whether these deregulations are i) correlated with different histo-prognostic parameters (pn (n= node), pt (t= tumor) , ev, til...) but also clinical ii) an independent prognostic parameter of bc in terms of disease-free survival, metastasis-free survival and overall survival. the cohort consists of 350 cases of bc, treated between 2009 and 2011 as well as all relevant clinical informations. in parallel, we will continue our preclinical work by characterizing the targets and mechanisms of action of ocdo. our preliminary results indicate that ocdo is a modulator of the glucocorticoid receptor (gr), which could be target to inhibit this pathway. on the other hand, we will characterize in the same manner as in human tumors, the deregulations of the ce metabolism in vitro and in vivo (including xenografts in mice of human tumors, in collaboration with roman-roman s) on a representative panel of bc molecular subtypes, sensitive or not usually administered in clinical treatment and study the anti-tumor effect of various "anti-ocdo" therapies (therapies preventing its production such as tam (tamoxifen) or dda, inhibitor of the enzyme producing ocdo, or an inhibitor of the gr (glucocorticoid receptor )), alone or in combination with conventional therapies


Eligibility criteria:
inclusion criteria: * age \> 18 years old * affiliated to the french social security system. * subjects must provide written informed consent prior to any study-specific procedure or assessment exclusion criteria: * pregnant or breastfeeding woman * subject law protected * any serious and/or unstable pre-existing psychiatric,familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures
modifications of the subchondral bone in aseptic osteonecrosis of the femoral head

Conditions: Femur Head Necrosis

Summary: in this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and raman spectrometry performed on the femoral heads removed during hip replacements. the study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. also, the association with preliminary mri analysis will provide pathogenic explanations correlated to these modifications.


Eligibility criteria:
inclusion criteria for experimental group: * men * patients aged from 25 to 70 years * patient with an aseptic osteonecrosis of the femoral head established by medical imaging (ct-scan, mri or radiography) * ficat stage 3 or 4 * osteonecrosis etiologies : alcohol, corticosteroid therapy, idiopathic * surgical indication of hip prosthesis determined inclusion criteria for control group: * men * patients aged from 40 to 70 years * patient with a primitive coxarthrosis * surgical indication of hip prosthesis determined exclusion criteria for the 2 groups: * other causes of osteonecrosis (coagulopathy, barotrauma, trauma) * prior fracture of the upper extremity of the femur * prior cancer and hematological malignancies with bone locations * prior debilitating bone diseases * patient refusal to participate in the study * patient who isn't affiliated to a social security regimen

Keywords: aseptic osteonecrosis femoral head micro scanner raman spectrometry mri
colorectal cancer survivors' needs and preferences for survivorship information

Conditions: Colon Cancer; Rectal Cancer

Summary: we are doing this study to learn more about colon and rectal cancer survivors. we want to know if survivors want more information about life after cancer. do cancer survivors want to know more about their own cancer? do cancer survivors want to know about their treatment? do cancer survivors want to know what health care they should get in the future? we want to know what information to give to cancer survivors when they finish treatment.


Eligibility criteria:
inclusion criteria: * 18 years of age or older at diagnosis * diagnosed with first primary colorectal cancer (stage i-iii) * completed last treatment for colorectal cancer (surgery, chemotherapy, or radiation) at least 6 months and no more than 2 years before the date of study enrollment * able to speak english, because questionnaire is only available in english * able to provide informed consent * received all treatment for colorectal cancer at mskcc or qcc or, surgical treatment at an outside facility, and all other treatment (chemotherapy or radiation) at mskcc or qcc exclusion criteria: * undergoing active treatment for colorectal cancer * diagnosed with metastatic colorectal cancer * prior history of colorectal or any other cancer (except non-melanoma skin cancer) * diagnosed with new or recurrent colorectal or other cancer after the primary colorectal cancer diagnosis * received a survivorship care plan from the treating institution

Keywords: survivorship quality of life questionnaire 09-133
topical nitrates for myofascial trigger points

Conditions: Myofascial Trigger Points

Summary: the purpose of this study is to determine whether a topical nitroglycerine patch applied daily over a trapezius trigger point can improve patients' symptoms. if there is improvement, this open label study will help determine the degree of improvement and contribute to the design of a larger double blind placebo controlled trial. we would consider moving forward to a large randomized trial if: * the intervention is acceptable to patients (\>= 70%) and * compliance is satisfactory (\>=80%) and * we find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the vas.


Eligibility criteria:
inclusion criteria: * inclusion criteria include age between 19 and 65 years old, myofascial pain lasting at least 6 months, and a myofascial trigger point point in the trapezius muscle. exclusion criteria: * our exclusion criteria include symptomatic disc herniation, symptomatic cervical osteoarthritis, systemic infection, malignancy, collapsed vertebra, thoracic outlet syndrome, temporomandibular joint dysfunction, collagen-vascular disease, or brachial plexopathy. patients with ongoing litigation regarding their symptoms are not eligible for this study. also excluded are patients with underlying cardiac disease, hypotension, or medical conditions that may not allow them to tolerate the use of vasodilators, and those who use phosphodiesterase inhibitors.

Keywords: myofascial pain trigger point nitroglycerin
safety and efficacy of cariprazine as adjunctive therapy in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is an outpatient study to evaluate the safety, and efficacy of rgh-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.


Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * currently meet the dsm-iv-tr criteria for moderate to severe mdd without psychotic features. * previous failure to respond to adequate trials of one or two adts with less than 50% reduction in depressive symptoms during the present episode. exclusion criteria: * dsm-iv-tr based diagnosis of an axis i disorder, other than mdd, or any axis i disorder other than mdd that was the primary focus of treatment within 6 months before visit 1

Keywords: adjunctive depression major depressive disorder (mdd)
a study of creatine combined with curcumin in the intervention of early cachexia in upper gastrointestinal tumors

Conditions: Stage IV Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage III Esophageal Cancer; Stage IV Esophageal Cancer

Summary: cachexia is a common complication of various advanced malignant tumors, which seriously affects the quality of life and survival time of patients. in view of the clinical problem of non-nutritional response in patients with cachexia, the investigators plan to carry out a clinical case-control study on the intervention of creatine combined with curcumin in participants with cachexia. on the whole, the investigators limited the study subjects to upper digestive tract tumors and diagnosed participants with early cachexia. the main purpose of this study is to determine whether the combination of the two can play a positive and stable role in inhibiting the inflammation of cachexia and improving metabolic status, so that basic nutrition can play a role, in order to reduce the level of skeletal muscle consumption, maintain weight, improve quality of life, save medical costs and extend survival time.

this is a prospective open controlled study. the intervention is targeted at participants with early cachexia in upper gastrointestinal tumors.both control group and intervention group receive basic nutritional support. on the basis of this, the intervention group will be given creatine and curcumin orally.the purpose is to investigate whether creatine combined with curcumin can improve the inflammatory and the nutritional state, correct the disorder of nutrient metabolism and improve the prognosis of participants.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of advanced tumors of the upper digestive tract with untreatable or postoperative recurrence of esophageal and gastric cancer iii-iv * meet the diagnostic criteria of early cachexia (anorexia and metabolic changes, involuntary body mass reduction ≤5% within 6 months) * radiotherapy, chemotherapy or immunotherapy in our hospital * understand and fill in a variety of rating scales * informed consent, voluntary participation in this study exclusion criteria: * neoadjuvant chemotherapy patients * intestinal obstruction or gastrointestinal bleeding * severe heart, lung and renal insufficiency * coagulopathy * clinical diagnosis with diabetes and other metabolic diseases * the expected survival time is less than 1 month * with cognitive dysfunction or poor coordination * allergy to creatine or curcumin * with a history of drug abuse * doctors or researchers deem unsuitable for study participation

Keywords: creatine cur-cumin early cachexia
safety awareness for empowerment (safe): an rct with young people experiencing homelessness

Conditions: Substance Use; Victimization

Summary: the safe study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.

youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to receive the safe intervention (plus usual case management) or to receive usual case management only. those assigned to safe will receive 12 mindfulness-based, cognitive-behavioral modules through a 3-day intensive group intervention provided by an agency intern and a hired project staff member. the intervention uses mindfulness-based cognitive-behavioral approaches to augment youth attention to risk-related processes, including risk detection, problem solving, assertiveness, and help seeking skills. it is hypothesized the intervention will result in reduced substance use and victimization and that these effects will be explained, at least in part, by improved risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking skills). post baseline interview, participants will be randomly assigned and will participate in a posttest interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months post baseline interview.

Eligibility criteria:
inclusion criteria: * reside at the partnering community based youth shelter exclusion criteria: as measured by the ksads (a semi-structured diagnostic interview administered by trained interviewers at baseline): * presence of psychotic symptoms; * presence of a life-threatening medical/chronic neurological illness that would prevent participation in a 4-day intervention and/or assessments; * suicide attempt in last 6 months without current enrollment in therapy or related services to address; * chronic self-injurious behavior/cutting without current enrollment in therapy or related services to address * hospitalization or residential treatment for psychiatric reasons in last 6 months without current enrollment in therapy or related services to address.

Keywords: substance use victimization homeless youth youth experiencing homelessness